The present invention relates generally to enteral feeding devices, and more particularly to an in-line connector between components of the feeding system.
It is a known medical procedure to catheterize a body in order to provide nutritional solutions directly into the stomach or intestines of a patient. A stoma is formed in the stomach or intestinal wall and a gastrostomy catheter device is placed through the stoma. This device is supplied with a nutritional solution via a tube, adapter, infusion set, or any combination of devices for delivering the nutritional solution for direct injection into a patient's stomach or intestines. This process is referred to as enteral feeding.
To ensure that the gastrostomy device is maintained in the proper position, it is common to use a balloon disposed near the distal (patient) end of a catheter shaft component of the device. Inflating the balloon causes the balloon to contact the anatomical structure (i.e., a duct or stomach wall) and thereby prevent the catheter from moving out of the proper position. Such balloon gastrostomy devices may include a “low-profile” head at the proximal end of the catheter shaft. The head, which also helps hold the balloon catheter in place, includes an opening for receiving the feeding solution and a one-way valve for preventing fluids from passing out of the patient via the catheter. U.S. Pat. Nos. 5,997,503 and 5,997,546 disclose examples of low-profile balloon catheter gastrostomy devices suitable for enteral feeding, and are incorporated by reference herein for all purposes.
An enteral feeding adapter is often used to transfer the solutions from an upstream source to the gastrostomy device, and typically includes an elongate tube having a distal end that engages in the head of the gastrostomy device. This tube typically extends at least partially through the device and maintains the one-way valve in the catheter in an open position during the enteral feeding process. The adapter may be connected directly to a feeding tube or to an infusion set that is, in turn connected to an enteral feeding pump, a drip chamber, or any other mechanism for providing the feeding solution.
A serious problem associated with this configuration and process is that the feeding tube and adapter may accidentally separate during the feeding process and disrupt the flow of nutritional fluids to the patient. In addition, the nutritional solution and any medicine will spill over the patient. The tube connected to the gastrostomy device provides an open pathway to the patient's stomach, and gastric juices will leak out of the tube. These juices can cause burns and other complications.
Solutions to noted problem have been proposed in the art. For example, U.S. Pat. Nos. 5,057,093; 5,322,073; and 5,554,140 describe interlock devices integrally formed with the feeding devices to secure the components together. Clamping devices are also disclosed in U.S. Pat. Nos. 4,230,109 and 5,248,306. U.S. Pat. No. 6,375,231 discloses another proposed solution wherein a clamp secures a feeding adapter in position relative to a feeding device. The clamp includes C-shaped members integrally connected by elastic webs. One of the members attaches to the feeding adapter, and the other member attached to the feeding device. Elastic bands are used to secure the C-shaped members to their respective components.
The present invention provides a novel solution to the problem of separation of in-line components in an enteral feeding system that does not depend on axially clamping separate feeding members together.